According to an analysis conducted by BioWorld of the third-quarter 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the nine-month period increased by almost 21% compared to the same period last year. The spending was bolstered by companies turning their attention to focus their research on therapies and vaccines to tackle COVID-19.
The 105 companies that were included in the analysis collectively invested a total of $30.4 billion on R&D compared to almost $25.2 billion invested last year.
The top 20 companies, ranked by total R&D spending, spent a combined $21 billion, or 69%, of the group’s total R&D expenses. (See Top 20 biopharmaceutical companies by R&D spending in 1Q-3Q 2020, below.)
There is no doubt that many biopharma companies have quickly devoted their R&D investments toward discovering a therapeutic or vaccine that will halt the spread of the deadly COVID-19 pandemic.
In its third-quarter financial results, Cambridge, Mass.-based Moderna Inc. reported that its R&D expenses were $611.5 million for the nine months ended Sept. 30, compared to $378.4 million for the same period in 2019, an increase of 62%, which the company attributed to increases in clinical trial expenses, raw materials and manufacturing costs and an increase in personnel-related costs.
In the period, it fully enrolled its phase III COVE study of COVID-19 vaccine candidate mRNA-1273, being conducted with the U.S. NIH and the Biomedical Advanced Research and Development Authority, with 30,000 participants, including 37% from diverse communities and 42% at high-risk of severe disease (>65 years or co-morbid risk factors).
Biontech SE along with Pfizer Inc. scored a major win this week in their phase III trial with COVID-19 vaccine BNT-162b2, gaining 90% efficacy in preventing infection at the first interim analysis by an external, independent data monitoring committee (DMC). The study enrolled 43,538 subjects, 42% of diverse backgrounds globally, and no safety concerns turned up.
The speed and scale of the study was clearly reflected in Biontech’s third-quarter financial results. For the nine-month period ended Sept. 30, its total R&D expenses were €388 million (US$458 million), compared to €161 million (US$190 million) for the comparative prior year period. The increase, the company said, was mainly due to an increase in development expenses from the BNT-162 vaccine program.
Foster City-based Gilead Sciences Inc. ranked first with $3.4 billion in recorded R&D expenses, an increase of about 17% over last year’s spending over the nine-month period. This was primarily due to higher clinical trial expenses related to remdesivir and increased investments in oncology programs, including magrolimab, partially offset by lower costs as a result of Gilead’s pause or postponement of certain clinical trials due to the COVID-19 pandemic.
In September, the company announced that the FDA granted breakthrough therapy designation for magrolimab, a potentially first-in-class, investigational, monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS). The designation was based on positive results from an ongoing phase Ib study evaluating magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
Sarepta Therapeutics Inc. reported that the 52% increase in its R&D expenses of $515.1 million this year reflects a total of $165.8 million it spent on manufacturing as it continues to ramp up its gene therapy programs.
At the end of September, the Cambridge, Mass.-based company released positive results from an ongoing study of SRP-9003 (rAAVrh74.MHCK7.hSGCB), its investigational gene therapy for limb-girdle muscular dystrophy type 2E (LGMD2E). Results included 18-month functional data from three clinical trial participants in the low-dose cohort and six-month functional data from three participants in the high-dose cohort. SRP-9003 is in development for the treatment of LGMD2E (also known as beta-sarcoglycanopathy and LGMDR4), a devastating monogenic neuromuscular disease caused by a lack of beta-sarcoglycan proteins. SRP-9003 is a gene construct that transduces skeletal and cardiac muscle, delivering a gene that codes for the full-length beta-sarcoglycan protein, the absence of which is the sole cause of the progressive degeneration and a shortened lifespan characterized by the disease, the company explained.
By the numbers
There are 136 public biopharmaceutical companies with market caps greater than $1 billion and their collective market valuation is a whopping $898 billion, or approximately 75% of the value of the total number of public biopharma companies tracked by BioWorld.